Today, the US Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test, which detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The test can be performed in an environment where a patient sample is both collected and analyzed, such as a doctor’s office, hospital, and mobile testing sites, using a device about the size of a carry-on luggage. The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe the test and can provide results in less than three minutes.
“Today’s authorization is another example of the rapid innovation that is happening with clinical trials for COVID-19,” said Jeff Shuren, JD, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position America for the next public health emergency.”
The performance of the InspectIR COVID-19 Breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test showed 91.2% sensitivity (percentage of positive samples tested correctly) and 99.3% specificity (percentage of negative samples tested correctly). The study also showed that, in a population of only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that those who received a negative test result were probably less likely to be tested. areas are really negative. disease spread. A follow-up clinical study focused on the Omicron type was tested with similar sensitivity.
The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection with breath. ) is detected rapidly. When the InspectIR COVID-19 Breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and must be confirmed with molecular testing. Negative results should be considered in the context of the patient’s recent exposure, history, and the presence of clinical signs and symptoms consistent with COVID-19, as they do not rule out SARS-CoV-2 infection and are the sole basis should not be used as For treatment or patient management decisions, including infection control decisions.
InspectIR expects to be able to produce about 100 instruments per week, which can be used to evaluate approximately 160 samples per day. At this stage of production, the testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase to around 64,000 samples per month.,
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by assuring the safety, effectiveness, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, electronic radiation release products, and tobacco products regulating it.